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FDA 510(k), K141109, APERIO EPATHOLOGY EIHC IVD SYSTEM
FDA 510(k), K141109, APERIO EPATHOLOGY EIHC IVD SYSTEM
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510(K) Number: K141109
Device Name: APERIO EPATHOLOGY EIHC IVD SYSTEM
Manufacturer: LEICA BIOSYSTEMS IMAGING, INC.
Device Classification Name: microscope, automated, image analysis, operator intervention
Regulation Number: 864.1860
Classification Product Code: NOT
Date Received: 04/29/2014
Decision Date: 07/29/2014
Regulation Medical Specialty: Hematology
Device Name: APERIO EPATHOLOGY EIHC IVD SYSTEM
Manufacturer: LEICA BIOSYSTEMS IMAGING, INC.
Device Classification Name: microscope, automated, image analysis, operator intervention
Regulation Number: 864.1860
Classification Product Code: NOT
Date Received: 04/29/2014
Decision Date: 07/29/2014
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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